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A phase II Study of Useful therapeutic strategy for metastatic Colorectal Cancer to Evaluate Oxaliplatin Stop and Go in SOX+Bmab

Phase 2
Conditions
Colorectal Cancer
Registration Number
JPRN-UMIN000007411
Lead Sponsor
wajima City Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1)Contraindication of TS-1, Oxaliplatin and Bevacizumab. 2)Patients with severe complications,(heart failure, renal failure, liver failure, peptic ulcer hemorrhage, intestinal paralysis, intestinal obstruction, Peritonitis or uncontrollable diabetes mellitus or hypertension) 3)Patients with History of severe drug allergy, pulmonary fibrosis, interstitial pneumonitis, Thrombosis/embolism, Cerebral infarction, pulmonary infarction or hemoptysis. 4)Patients with severe diarrhea 5) Patients with sensory neuropathy 6)Patients with serious infections or susupected infections with fever(over 38 degree) 7)HBs Ag is positive 8)Complication of ascites or pleural effusion requiring treatment such as the drainage 9) Patients with the primary tumor with the high-grade stenosis as an endoscope do not pass.( However, the case of excision of the primary tumor or the stoma is possible.) 10) Patients with the peritoneal metastasis which we can confirm with an image 11)concomitant therapy with flucytocine, phenytoin or warfarin 12)Pregnant, breast feeding, or men in hope of Pregnancy of partner. 13)Relapse of administering period and less than 6 months of TS-1 or Oxaliplatin. 14) Patients with the continuous systemically administration of steroid. 15) Active concomitant malignancy with less than five years in disease free interval. 16)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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